Drug industry moves to police its ads

Guidelines for direct-to-consumer ads get preliminary OK

By

KristenGerencher

Reporter

SAN FRANCISCO (MarketWatch) -- In a move to counter growing criticism of direct-to-consumer advertising of medicines, a drug-company trade group has given preliminary approval to a campaign that encourages member companies to self-police their promotions.

The Pharmaceutical Research and Manufacturers of America's (PhRMA) board of directors gave preliminary approval last week to what it calls guiding principles on direct-to-consumer (DTC) advertising of prescription drugs.

The guidelines suggest companies have conversations with physicians before launching a new DTC campaign. Other ideas include targeting TV ads for audience and age appropriateness, promoting health and disease awareness and encouraging companies to list information about assistance programs for people with low incomes or who don't have health insurance.

PhRMA Senior Vice President Ken Johnson said the board is still working out some of the principles but has approved the substance of the code. The guidelines are expected to be announced in full the first week of August.

In the future, drug companies' ads "should include a greater explanation of not only of [a drug's] benefits but also risks," Johnson said. "Additionally, we believe the ads should be more educational and informational, stressing the patient-physician relationship."

PhRMA member companies spent $3.3 billion on print and TV ads in 2003.

Critics maintain the guidelines will do little to protect consumers and are meant to shore up pharmaceutical companies' flagging image in the wake of the Vioxx recall and of incidents where other drugs proved more harmful than believed after receiving marketing approval.

Fighting an image problem

Dr. Sidney Wolfe, director of the health research group at consumer watchdog Public Citizen, called the PhRMA effort "window-dressing."

"I wouldn't have any great hopes," Wolfe said. "Given the all-time low public opinion of the drug industry, this is the kind of desperate [public relations] campaign one might expect."

"There is so little in this that it would not be difficult for most if not all companies to abide by it," he added. "I'm not sure what difference it would make."

Earlier this year, a survey of 1,200 adults from the Kaiser Family Foundation found that half of consumers have an unfavorable view of the pharmaceutical industry despite acknowledging the widespread benefits of prescription drugs and a general confidence in their safety.

Ads for prescription medications are ubiquitous but they appear to fall short on credibility. Nine out of 10 adults have seen or heard an ad, the survey said. But fewer than two in 10 said they can trust what drug companies say in their ads "most of the time," down from 33% who found them mostly trustworthy in 1997.

The U.S. Food and Drug Administration is doing "very little" to enforce its laws and regulations related to DTC advertising, Wolfe said.

Companies don't have to submit their ads for approval before running them, but the FDA monitors ads for any misleading information. The agency sent letters urging 157 drug ads to stop running in 1998, a number that dwindled to 24 last year despite a substantial rise in the amount of money spent on such ads, Wolfe said.

Lawmakers take notice

Drugmakers would do well to impose a two-year moratorium on consumer advertising for newly approved drugs, Wolfe said.

Senate majority leader Bill Frist proposed such an idea earlier this month, and Bristol- Myers Squibb
BMY, +0.73%
said in June it would delay branded advertising for its new drugs by a year.

Imposing temporary bans on DTC advertising is an idea that bears watching, said Ashley Turton, chief of staff for U.S. Rep. Rosa DeLauro, D-Conn.

What's more, lawmakers doubled funding for the FDA office that reviews DTC drug ads to $1.7 million for 2006 from $860,000 today, she said.

In a separate but related move, Hoffman-La Roche, a subsidiary of Roche
RHHVF, +0.95%
announced it is launching a generic public awareness campaign about Hepatitis C, which kills 8,000 to 10,0000 Americans each year and affects about 1 million.

Unbranded print ads say, "If Hep C was attacking your face instead of your liver you'd do something about it. Ready to fight back?" Like many TV ads, it asks consumers to "talk to your doctor about prescription treatment," though it doesn't promote a Roche product.

However, the online site, www.hepCsource.com, is branded with Roche's sponsorship on the bottom of the page and a link to information on the company's drug treatment called Pegasys. See the Web site.

Overall, Johnson of PhRMA said skeptics will be proved wrong when ads become more informational and educational. "Can we do a better job? Yes, and we will. But we also believe patients have a right to know about new drugs which can improve their health and quality of life."

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